Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia

The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy

AML is the most common leukemia diagnosed in adults. In spite of recent low-intensity therapies that have improved outcomes for older AML patients, AML remains associated with poor prognosis as well as high symptom burden. While the benefits of early palliative care as well as electronic PROs have been well-described in the oncology population, neither have been well-studied in the AML population, and have never been studied in combination. We propose a prospective, single-center, single-arm trial to evaluate the feasibility of a virtually-mediated supportive care model utilizing both electronic PROs and palliative care for patients with AML being treated with low-intensity therapy.

AIM1: is to evaluate and describe the feasibility of implementing early specialty palliative care referrals carried out via telehealth/video-based modalities in combination with digital symptom monitoring for patients recently diagnosed with acute myeloid leukemia (AML) and starting low intensity induction therapy.

AIM2: study the differences in health-related quality-of-life (HRQoL) metrics using patient-reported outcomes (PROs) in patients recently diagnosed with AML and starting low intensity induction therapy who receive early referral to telehealth/video-based palliative care visits compared to standard care.

AIM3: to explore the patient experience of patients with AML on low-intensity therapy, capture rates of advance care planning, hospice utilization, and hospital utilization.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Palliative Care + Digital Symptom Monitoring

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients being treated for a diagnosis of acute myeloid leukemia at Stanford Cancer Center
• Patients determined to be candidates for low intensity induction therapy (not requiring hospitalization to administer treatment) by their leukemia physician
• Estimated life expectancy of 6 months
• Functional status at the level of at least being capable of limited self-care, confined to chair or bed for half the day or better
• Access to smartphone, tablet, or computer with capability to utilize a symptom tracking application

Exclusion Criteria:

• Relapsed or refractory AML
• Patients who have established care with palliative care previously
• Non-English-speaking, as the Noona application is developed in the English language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients; All patients enrolled in this trial will be referred to palliative care for planned monthly virtual visits, be instructed on the use of a digital application Noona that can be downloaded on their personal electronic device, and will be prompted to fill out symptom questionnaires using Noona prior to palliative care visits (required) as well as weekly (optional).	Other: Palliative Care + Digital Symptom Monitoring; Previously described in Arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of completed palliative care referrals and monthly visits	This will be measured as a percentage of patients who overall complete the initial palliative care referral and at least 50% of their scheduled monthly visits	Through study completion, an average of 6 months
Rate of usage of digital symptom monitoring application, Noona	This will be measured by the percentage of patients who complete at least 50% of Noona surveys associated with their palliative care visits	Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores	Health-related quality of life instrument used in patients with acute myeloid leukemia, minimum score 0, maximum score 176, higher scores indicating worse quality of life	Baseline, 3 months, and 6 months
Mean change in Hospital Anxiety and Depression Scale (HADS) scores	Hospital Anxiety and Depression survey used to measure anxiety and depression, minimum score 0, maximum score 42, with higher scores indicating increased anxiety/depression	Baseline, 3 months, and 6 months
Mean change in Patient Health Questionnaire (PHQ)-9 scores	Minimum score 0, maximum score 27, with higher scores indicating worse mood	Baseline, 3 months, and 6 months
Mean change in Satisfaction with Decision-Making Scale scores	Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction	Baseline, 3 months, and 6 months
Overall satisfaction with usage of Noona questionnaire	Measured qualitatively, by whether patients strongly agree, somewhat agree, are neutral, somewhat disagree, or strongly disagree with statements regarding the Noona instrument	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Kavitha Ramchandran, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Palliative Care
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: IRB-60285; NCI-2022-03013 (Registry Identifier: CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No